System and method for the simultaneous automated bilateral delivery of pressure equalization tubes

• US 8,052,693 B2
• Filed: 05/16/2007
• Issued: 11/08/2011
• Est. Priority Date: 04/19/2007
• Status: Active Grant

• Current Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Shahoian, Erik James
• Primary Examiner(s): Hughes; Tom
• Assistant Examiner(s): MILES, JONATHAN WADE
• Application Number:
  US11/749,734
• Publication Number:
  US 20080262505A1
• Time in Patent Office: 1,637 Days
• Field of Search: 606/109, 606/185, 606/108, 606/181, 606/182, 606/183, 604/8, 604/244
• US Class Current: 606/109
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/227 for ears, i.e. otoscopes
• CPC Class Codes: A61B 2017/00787 Surgery of the ear
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
• CPC Class Codes: A61F 2230/0039 H-shaped
• CPC Class Codes: A61F 2230/0052 T-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0082 specially designed for children, e.g. having means for adjusting to their growth
• CPC Class Codes: A61M 2210/0662 Ears
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body

Abstract

Systems and methods for treating a patient having a head with a first ear and a second ear, function by aligning a first device with a tympanic membrane of the first ear; inputting a command to an input device operatively coupled to the first device to generate a signal; and actuating the first device in response to the signal so as to drive a penetrator of the device through the tympanic membrane.

Claims

1. A method for treating a patient, the patient having a head with a first ear and a second ear, the method comprising:

advancing a tube delivery device into the first ear of the patient;

aligning the tube delivery device with a tympanic membrane of the first ear;

verifying that the tube delivery device is within a desired range from the tympanic membrane, using a range finder of the tube delivery device;

inputting a command to an input device operatively coupled to the tube delivery device to generate a signal;

actuating the tube delivery device in response to the signal so as to drive a penetrator of the device through the tympanic membrane; and

deploying a tympanostomy tube with the tube delivery device, the tympanostomy tube advancing with the penetrator and the penetrator retracting back into the ear canal after releasing the tympanostomy tube;

wherein the tube delivery device comprises a first spring urging the penetrator distally through the tympanic membrane and a second spring urging the tympanostomy tube free of the penetrator and the penetrator proximally of the tympanic membrane, wherein the first and second springs are restrained and store mechanical energy prior to the signal and wherein the signal effects sequential release of the first spring and the second spring; and

wherein the signal comprises an electrical signal, the device comprising an electromechanical mechanism effecting axial movement of the penetrator.

2. The method of claim 1, wherein the input device is movably coupled to the tube delivery device so as to isolate a command movement and inhibit deviation from the alignment.

3. The method of claim 1, further comprising:

aligning a second tube delivery device with a tympanic membrane of the second ear; and

actuating the second device in response to the signal so as to drive a penetrator of the device through the tympanic membrane of the second ear, penetration of the tympanic membranes being synchronized by circuitry coupling the input device to the tube delivery devices.

4. The method of claim 1, further comprising damping the axial movement of the penetrator.

5. The method of claim 1, wherein the first and second springs are restrained by associated first and second electrically fusable members, and wherein the fusable members are coupled to the input device with a flex circuit bent around an axis of movement of the penetrator.

6. The method of claim 1, wherein the tympanostomy tube is radially constrained within a receptacle of the penetrator, and wherein the tympanostomy tube expands radially when released so as to inhibit expulsion.

7. The method of claim 1, wherein the tube delivery device is contained within a housing having an axial length of less that 15 mm and a maximum transverse dimension of less than 5 mm.

8. The method of claim 1, wherein the actuation of the penetrator has a stroke, and further comprising measuring an axial distance between the tympanic membrane and the penetrator so that the stroke penetrates the tympanic membrane by a desired amount.

9. The method of claim 1, wherein the patient is sitting upright.

10. The method of claim 1, wherein the penetrator is urged distally by the first spring and proximally by the second spring with respect to a stationary outer case of the tube delivery device.

11. The method of claim 1, wherein verifying comprises adjusting the position of the tube delivery device with respect to the tympanic membrane to align light projections of light emitting elements of the range finder, the light projections being projected onto the tympanic membrane.